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Completed

NCT Number: NCT04541940

TeleRehabilitation Following ACL Reconstruction

Telerehabilitation is a form of tele-treatment in which rehabilitation services are dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information. The advantages of telerehabilitation include reducing unnecessary travel to the hospital and person to person contact while maintaining social distancing. While some of the patients are truly staying at remote areas, others are unable to manage travel in the lockdown period. Telemedicine offers the opportunity to deliver rehabilitative services in the patients' home, closing geographic, physical, and motivational gaps. Punctuality on either side is also assured since the travel times are saved on both the ends.

The purpose of the proposed study is to evaluate telerehabilitation vs. in-person rehabilitation following ACL reconstruction. Objectives include assess return to sport and patient reported functional outcomes.

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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for ACL reconstruction
  • Age 18-40
  • Ability to comply with a standardized postoperative protocol
  • Willing and able to provide consent

Exclusion criteria

  • Pregnant patient
  • Age >40 years, or < 18
  • Previous knee surgery
  • Unable to speak English or perform informed consent

Treatment and study plan

Telerehabilitation Therapy

Other

Rehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.

In-person Rehabilitation Therapy

Other

Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.

Primary outcomes

  1. RTS (Return to Sport)

    Time frame: up to 1 year post-op

    The day when the participant is able to fully participate in their sport, but not at their desired performance level.

Secondary outcomes

  1. ACL-RSI Questionnaire Score

    Time frame: up to 1 year post-op

    ACL-RSI (anterior cruciate ligament - return to sport) consists of 12 questions. Each question is scored 0-100 with a total range of 0-1200. The higher the score, the more positive psychological outlook a participant has.

  2. Visual Analogue Scale (VAS) Score

    Time frame: up to 1 year post-op

    VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The total score ranges from 0-10. The higher the score, the worse the pain.

  3. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: up to 1 year post-op

    KOOS is a knee-specific instrument, developed to assess the participants' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales. Each subscale is calculated independently. The calculated mean score of the individual items of each subscale will be divided by 4. The total score range is 0-100. The lower the score, the more extreme the problems.

  4. International Knee Documentation Committee (IKDC) Score

    Time frame: up to 1 year post-op

    The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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